The American Cancer Society estimated a total of 1,372,910 new cancer cases and 570,280 cancer deaths in the U. S. in 2005. The National Cancer Institute solicits research proposals to develop cancer treatments via the Small Business Innovation Research funding mechanism. The long-term objective of Bexion Pharmaceutical Inc's research and development program is to evaluate the clinical benefits of Bexion's proprietary first-in-class biotherapeutic agent in treating common primary and metastasized cancers, including prostate cancer. The incident rate of 232,090 cases of prostate cancer is the highest among all cancers in men, and it is the second leading cause of death resulting in 30,350 deaths in the U.S. in men in the U.S. in 2005. The objective of the proposed research is to conduct pre-clinical proof-of-principle studies to show that the treatment agent is efficacious in reducing the size of primary as well as metastasized prostate cancer. In the specific aims of this project, we propose to evaluate the preclinical benefit of Bexion's treatment agent on (1) orthotopic and (2) metastasized prostate tumors in male athymic mice. To achieve these objectives, we will utilize the Caliper Life Sciences' bioluminescent prostate cancer cell line (PC-3M-luc-6M) to generate orthotopic and metastasized prostate cancer in athymic mice, and use Caliper's in vivo non-invasive imaging system to quantify the real-time effects of Bexion's treatment agent on the size of these tumors before, during and after treatment in individual mice. Prostate cancer is the leading cancer disease and is the second leading cause of cancer death in men. However, treatment options for the disease are limited. Bexion Pharmaceuticals, Inc. is developing a first-in-class cancer biotherapeutics that has the potential for the treatment of both primary and metastasized prostate cancer. [unreadable] [unreadable] [unreadable]